Early Institutionalization Intervention Impact Project

Not Applicable

Recruiting

• Conditions: Socioemotional Development; Cognitive Ability; Psychopathology; Behavioral and Neural Patterns of Attention; Brain Function

• Registration Number: NCT04165746
• Lead Sponsor: Boston Children's Hospital

Brief Summary

The purpose of this study is to determine the effects of early intervention (placement into foster care, and a caregiving training) on physical, cognitive, social and brain development and psychiatric symptomatology in children place in out-of-home care.

Detailed Description

The Early Institutionalization Intervention Impact (EI-3) Project will document and compare the impact of enhanced institutional care on early childhood development to that of high-quality foster care. We will recruit a large (n= 220) samples of young children who have been identified as having to be removed from their families and we will randomize these children to two groups: enhanced institutional care (Group 1) or to enhanced foster care (Group 2). Institutional caregivers and Foster Parents will participate in a caregiving training, along with the child, that includes 8-1.5 hour sessions over 8-9 weeks.

In this Randomized Control Trial (RCT), we will assess the children in Groups 1 and 2 at the time they come into care and then at several follow-up time points (12 months, 24 months, 36 months of age). We hypothesize that children placed into foster/family care (FCG) will display enhanced socioemotional development, and enhanced behavioral and neural patterns of attention, cognition and social cognition, compared to children placed in enhanced institutional care.

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Study Start: 2023-03-16
• Status Verified: 2024-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2028-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• newly entering the institution system in and near São Paulo, Brazil, and the institution director or foster parent is the guardian at the time of baseline,
• at the time of baseline assessment the child is less than 24 months old,
• the child's birth weight must be at or above 2500 grams; none should be small or large for dates.

Exclusion Criteria

• the child does not have a neurological or other genetic condition that severely impairs typical development (e.g. Cerebral Palsy, Fetal Alcohol Syndrome, Down Syndrome)
• the child is below 2500 grams.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Differences in security of attachment	baseline, 12 mos, 24 mos, 36 mos	Strange Situation Procedure
Differences in Alpha Electroencephalogram (EEG) Power, Coherence and Functional Connectivity	baseline, 12 mos, 24 mos, 36 mos	EEG power

Secondary Outcome Measures

Name	Time	Method
Differences in Competence	baseline, 12 mos, 24 mos, 36 mos	Infant Toddler Social Emotional Assessments- Revised. Range for competence is 0-66. Ratings are 0, 1, 2 on 33 items. Higher scores are better outcomes. T-scores of 35 or lower on the Competence scale are also termed "of concern."
Differences in Cognition in early Childhood	baseline, 12 mos, 24 mos, 36 mos	Mullen Scales of Early Learning, AGS Edition. For the subscales (Visual Receptions, Fine Motor, Gross Motor, Receptive, and Expressive Language), the minimum T-score is 20 and the maximum is 80. A higher score indicates a better outcome. The Composite Standard Score goes from 49 to 155; 155 is the best outcome.
Differences in Attachment Disturbances and Disorders	baseline, 12 mos, 24 mos, 36 mos	Disturbances of Attachment Interview

Trial Locations

Locations (1)

Instituto PENSI; 🇧🇷 São Paulo, Brazil